跳至主要内容
临床试验/NCT04404985
NCT04404985进行中(未招募)不适用

Endovascular vs Surgical Arteriovenous Fistula Outcomes

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
21
试验地点
1
主要终点
Physiological fistula maturity

研究概览

简要总结

Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. There are two techniques of creating AVFs either the traditional way with surgery( Surgical AVFs) or novel per-cutaneous technique Endo- AVFs.

Investigators will pilot an randomized clinical trial of endo-AVFs and surgical AVFs at University of Alabama at Birmingham to determine the feasibility of patient recruitment, randomization, and retention. This pilot study will set the stage for a full-scale randomized clinical trial in future.

详细描述

Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. Despite concerted efforts to improve surgical AVF outcomes during the past 20 years, many new AVFs fail to mature, even after interventions to salvage them (assisted maturation). Postoperative ultrasounds of immature AVFs frequently demonstrate decreased flow with narrowing at the anastomosis . Surgically created AVFs typically have a 90o angle at the anastomosis, yet computational fluid dynamics suggest that an anastomotic angle <30o improves the flow hemodynamics. Therefore, there has been great interest in novel AVF technologies to limit vascular injury and improve flow dynamics and maturation rates. The new technology evaluated herein (endovascular AVF (endo-AVF) has the potential to achieve these goals and reduce the cost of vascular access care.

Endo-AVF, a novel per-cutaneous technique of AVF creation, was approved by the FDA in 2018, and has been used in U.S. hemodialysis patients . In contrast to the surgical technique (the current standard), this non-surgical approach (1) minimizes vascular injury at the time of AVF creation and (2) creates a channel between the artery and vein with an angle approaching 0o. These two features provide a scientific rationale for superior maturation compared with that of surgical AVF Investigators will perform a single-center, prospective pilot randomized clinical trial. Investigators will recruit 80 patients who have advanced chronic kidney disease or on hemodialysis with a catheter ,who there pre- operative Ultrasound showed they are eligible to surgical or endo-vascular AVF. Participants will be randomized to one of two groups: an surgical AVF intervention group that will undergo a routine surgical fistula creation, or an endo-vascular AVF intervention group will undergo per-cutaneous fistula creation . Participants will be followed for 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study will include participants who are 18 years and older who are scheduled to have an AVF
  • preoperative ultrasound showed feasibility to have an endo-vascular AVF vs surgical upper arm AVF

排除标准

  • Age below 18 years
  • participants eligible for low forearm AVF ( radio-cephalic)

结局指标

主要结局

Physiological fistula maturity

时间窗: 0-6 weeks

Assess by ultrasound . To assess blood flow within the fistula.

次要结局

  • Clinical fistula maturity(6 weeks-6 months)
  • Fistula survival(0-2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alian Al-Balas

Associate Clinical Professor

University of Alabama at Birmingham

研究点 (1)

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